Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above
NCT ID: NCT05164731
Last Updated: 2022-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
880 participants
INTERVENTIONAL
2021-12-16
2022-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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3 months after two doses
the third does was given 3 months after two doses
SARS-CoV-2 Vaccine, Inactivated (Vero Cell)
the third does was given 3, 4, 5 or 6 months after two doses
4 months after two doses
the third does was given 4 months after two doses
SARS-CoV-2 Vaccine, Inactivated (Vero Cell)
the third does was given 3, 4, 5 or 6 months after two doses
5 months after two doses
the third does was given 5 months after two doses
SARS-CoV-2 Vaccine, Inactivated (Vero Cell)
the third does was given 3, 4, 5 or 6 months after two doses
6 months after two doses
the third does was given 6 months after two doses
SARS-CoV-2 Vaccine, Inactivated (Vero Cell)
the third does was given 3, 4, 5 or 6 months after two doses
Interventions
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SARS-CoV-2 Vaccine, Inactivated (Vero Cell)
the third does was given 3, 4, 5 or 6 months after two doses
Eligibility Criteria
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Inclusion Criteria
2. aged 18 years and above, after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.
3. Proven legal identity, could come each visit.
4. Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form.
Exclusion Criteria
2. Using blood products after basic immunization or receiving immunosuppressive therapy.
3. Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination.
4. Allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine);
5. History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
6. Diseases beyond drug control, such as high blood pressure, diabetes, asthma.
7. Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
8. Immunization with any vaccine within 14 days.
9. Any other situations judged by investigators as not suitable for participating in this study.
18 Years
ALL
Yes
Sponsors
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Yunnan Center for Disease Control and Prevention
OTHER
Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Jingsi Yang
Senior Technologist
Principal Investigators
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Yan Zheng
Role: PRINCIPAL_INVESTIGATOR
Yunnan Center for Disease Control and Prevention
Locations
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Mile City Centers for Disease Control and Prevention
Mile, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Jianmei Zhou
Role: primary
Other Identifiers
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20211102
Identifier Type: -
Identifier Source: org_study_id
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